Search results for "Tolerability"
showing 10 items of 372 documents
A 4-year study of the efficacy and tolerability of enzyme replacement therapy with agalsidase alfa in 36 women with Fabry disease
2009
Although Fabry disease is X linked and considered to affect primarily male hemizygotes, female heterozygotes may experience all the signs and symptoms of this metabolic disorder. This prospective, single-center, open-label, clinical trial was performed to evaluate the long-term response of female patients with Fabry disease to enzyme replacement therapy.Symptomatic women (average age = 47 years) enrolled in this 4-year study were treated with agalsidase alfa (Replagal, Shire HGT, Inc.) at a dose of 0.2 mg/kg, every other week for 4 years (N = 36). Clinical and biochemical assessments were conducted at 12-month intervals.The Mainz Severity Score Index, a measure of total disease burden, was …
Cizolirtine Citrate, an Effective Treatment for Symptomatic Patients with Urinary Incontinence Secondary to Overactive Bladder: A Pilot Dose-Finding …
2009
Abstract Background A dose-finding study was performed as the first step in the clinical development of the new drug, cizolirtine citrate. Objective To assess the efficacy and safety of cizolirtine citrate in overactive bladder with urinary incontinence. Design, setting, and participants Seventy-nine outpatients with clinical overactive bladder and/or urodynamic diagnosis of detrusor overactivity were randomized in a multicentre, 12-wk, double-blind, pilot trial. Interventions Patients received cizolirtine citrate 400mg bid (C400), cizolirtine citrate 200mg bid (C200), or placebo. Measurements Patients recorded efficacy variables in 7- and 14-d bladder diaries: urinary incontinence episodes…
Pharmacological interventions for somatoform disorders in adults
2014
BACKGROUND: Somatoform disorders are characterised by chronic, medically unexplained physical symptoms (MUPS). Although different medications are part of treatment routines for people with somatoform disorders in clinics and private practices, there exists no systematic review or meta-analysis on the efficacy and tolerability of these medications. We aimed to synthesise to improve optimal treatment decisions.OBJECTIVES: To assess the effects of pharmacological interventions for somatoform disorders (specifically somatisation disorder, undifferentiated somatoform disorder, somatoform autonomic dysfunction, and pain disorder) in adults.SEARCH METHODS: We searched the Cochrane Depression, Anxi…
Therapy of Early Poststroke Depression With Venlafaxine: Safety, Tolerability, and Efficacy as Determined in an Open, Uncontrolled Clinical Trial
1999
To the Editor: The development of persistent depressive symptoms is a severe and frequent complication of ischemic or hemorrhagic stroke.1 The etiology of poststroke depression is not well understood. Only few placebo-controlled, double-blind studies have been carried out, all reporting various degrees of superiority of standard antidepressants over placebos.1 2 On the other hand, serious side effects have been reported.3 4 In most of these studies, patients were examined whose stroke had occurred several weeks to several months before the antidepressive therapy was started. Antidepressive therapy in the first weeks after stroke has not yet been attempted in studies. Drug-induced improvemen…
Idebenone in senile dementia of Alzheimer type: A multicentre study
1992
Idebenone is a new cerebro-active drug, effective in dementia disorders, particularly indicated in primary degenerative dementias, i.e. Alzheimer's disease. This new molecule acts as an electron trapper and a free radical scavenger protecting mitochondrial membranes from lipid peroxidation. A multicentric, double-blind trial of idebenone (45 mg twice daily orally) vs. placebo was carried out on 102 elderly patients affected by Alzheimer-type dementia of mild or moderate severity. Idebenone was administered for 4 consecutive months, 45 mg twice daily. Clinical evaluations were performed at the time of enrollment (t0) and monthly thereafter (t30, t60, t90 and t120) and at follow-up (t150 ). T…
Sequential Therapy with Azelastine in Seasonal Allergic Rhinitis
2011
A sequential therapy treatment with azelastine (Allergodil (r) ) in seasonal allergic rhinitis is introduced. In the critical early stage, treatment begins with a combination of azelastine tablets (azelastine hydrochloride, CAS 79307-93-0) and azelastine nasal spray (azelastine, CAS 58581-89-8), and after five days only the nasal spray is administered. This sequential therapy model aims at achieving the quickest and most complete effect without reducing the tolerability. The investigation was carried out as a randomized, controlled double-blind phase IV study of parallel group design with 300 patients during 14 days. In the first five days, one group was given one puff (0.14 mg) of azelasti…
Novel Insights and Therapeutical Applications in the Field of Inhibitors of COX-2
2004
The discovery of the two isoenzymes COX-1 and COX-2 and the knowledge of their function, localisation and regulation has initiated the development of COX-2 selective inhibitors (coxibs). Inducible COX-2 at the peripheral site of inflammation has been detected in the early 1990s, the involvement of recently detected spinal COX-2 has led to new insights into mechanisms of pain and may explain analgesic and antipyretic properties of COX-2 selective inhibitors. The coxibs rofecoxib and celecoxib have been introduced into therapy and seem to offer some advantages over the classical non-selective NSAIDs. The search for new COX-2 inhibitors is going on, the development of etoricoxib and lumiracox…
Role of ARBs in the blood hypertension therapy and prevention of cardiovascular events
2009
Hypertension has a worldwide high incidence in the general population and undoubtedly it is the most important risk factor for cardiovascular morbidity and mortality, in industrialized countries. In this Review we investigated the role of angiotensin II receptor antagonists (ARBs) therapy in the treatment of essential hypertension. We selected in the PubMed and in a list of selected sources the most significant clinical trials and meta-analysis carried out from 1999 to now, to assess, in adult patients populations, ARBs efficacy, safety and tolerability profile, in comparison with the efficacy of the other common antihypertensive drugs, with particular regard to both the prevention of disab…
ETC-1002: A future option for lipid disorders?
2014
ETC-1002 is a new investigational low density lipoprotein cholesterol (LDL-C)-lowering agent (Esperion Therapeutics, Inc.). ETC-1002 is a dicarboxylic acid derivative with a novel mechanism of action targeting two hepatic enzymes - adenosine triphosphate-citrate lyase (ACL) and adenosine monophosphate-activated protein kinase (AMPK), inhibiting sterol and fatty acid synthesis and promoting mitochondrial long-chain fatty acid oxidation. This agent is currently in phase II clinical research. Available data report that ETC-1002 significantly decreased LDL-C levels (up to 32%) in both patients with normal and elevated baseline levels of triglycerides. Such beneficial effect is superior to curre…
Safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of the novel enzyme replacement therapy avalglucosidase alfa (neoG…
2019
This multicenter/multinational, open-label, ascending-dose study (NCT01898364) evaluated safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of repeat-dose avalglucosidase alfa (neoGAA), a second-generation, recombinant acid α-glucosidase replacement therapy, in late-onset Pompe disease (LOPD). Patients ≥18 years, alglucosidase alfa naïve (Naïve) or previously receiving alglucosidase alfa for ≥9 months (Switch), with baseline FVC ≥50% predicted and independently ambulatory, received every-other-week avalglucosidase alfa 5, 10, or 20 mg/kg over 24 weeks. 9/10 Naïve and 12/14 Switch patients completed the study. Avalglucosidase alfa was well-tolerated; no deaths…